Background: Administrative claims for aortic stenosis (AS) regurgitation may be useful, but their accuracy and ability to identify individuals at risk for valve-related outcomes have not been well characterized. Methods: Using echocardiographic (transthoracic echocardiogram [TTE]) reports linked to US Medicare claims, 2017 to 2018, the performance of candidate International Classification of Diseases, Tenth Revision claims to ascertain AS/aortic regurgitation was evaluated. The optimal performing algorithm was tested against outcomes at 1-year after TTE in a separate 100% sample of US Medicare claims, 2017 to 2019. Results: Of those included in the derivation (N=5497, mean age 74.4±11.0 years, 49.7% female), any AS or aortic regurgitation was present in 24% and 38.8%, respectively. The sensitivity and specificity of International Classification of Diseases, Tenth Revision code I35.0 for identification of any AS was 53.1% and 94.8%, respectively. Among those with an I35.0 code, 40.3% had severe AS. Claims were unable to distinguish disease severity (ie, severe versus nonsevere) or subtype (eg, bicuspid or rheumatic AS), and were insensitive and nonspecific for aortic regurgitation of any severity. Among all beneficiaries who received a TTE (N=4 033 844), adjusting for age, sex, and 27 comorbidities, those with an I35.0 code had a higher adjusted risk of all-cause mortality (adjusted hazard ratio, 1.33 [95% CI, 1.31–1.34]), heart failure hospitalization (adjusted hazard ratio, 1.37 [95% CI, 1.34–1.41]), and aortic valve replacement (adjusted hazard ratio, 34.96 [95% CI, 33.74–36.22]). Conclusions: Among US Medicare beneficiaries receiving a TTE, International Classification of Diseases, Tenth Revision claims, though identifying a population at significant greater risk of valve-related outcomes, failed to identify nearly half of individuals with AS and were unable to distinguish disease severity or subtype. These results argue against the widespread use of International Classification of Diseases, Tenth Revision claims to screen for patients with AS and suggests the need for improved coding algorithms and alternative systems to extract TTE data for quality improvement and hospital benchmarking.

Opioid use disorder (OUD) is a chronic disease requiring long-term treatment and is associated with opioid overdose and increased risk of mortality. However, existing randomized clinical trials focused on short-term treatment engagement and detoxification rather than overdose or mortality risk due to limited follow-up time and ethical considerations. We used a hypothetical trial framework to conduct a retrospective cohort study to assess the effectiveness of time-varying buprenorphine-naloxone on opioid overdose and death. We identified 58,835 insured adult patients with OUD diagnosis in the US, 2010–2017. We fit a marginal structural model using inverse probability weighting methods to account for measured baseline and time-varying confounders, as well as selection bias due to possibly differential loss-to-follow-up. We found that receipt of buprenorphine-naloxone was associated with reduced risk of opioid overdose (hazard ratio (HR) = 0.66, 95% confidence interval (CI): 0.49, 0.91), death (HR = 0.24, 95% CI: 0.08, 0.75), and overdose or death (HR = 0.58, 95% CI: 0.40, 0.84). The E-value for death was 7.8, which was larger than the upper 95% CI of the association between each measured baseline variable and all-cause death, which implies that the unmeasured confounding itself may not explain away the estimated effect of treatment on the endpoint of all-cause mortality.

Background:Concerns have been raised about the long-term performance of aortic stent grafts for the treatment of abdominal aortic aneurysms, in particular, unibody stent grafts (eg, Endologix AFX AAA stent grafts). Only limited data sets are available to evaluate the long-term risks related to these devices. The SAFE-AAA Study (Comparison of Unibody and Non-Unibody Endografts for Abdominal Aortic Aneurysm Repair in Medicare Beneficiaries Study) was designed with the Food and Drug Administration to provide a longitudinal assessment of the safety of unibody aortic stent grafts among Medicare beneficiaries. Methods:The SAFE-AAA Study was a prespecified, retrospective cohort study evaluating whether unibody aortic stent grafts are noninferior to non-unibody aortic stent grafts with respect to the composite primary outcome of aortic reintervention, rupture, and mortality. Procedures were evaluated from August 1, 2011, through December 31, 2017. The primary end point was evaluated through December 31, 2019. Inverse probability weighting was used to account for imbalances in observed characteristics. Sensitivity analyses were used to evaluate the effect of unmeasured confounding, including assessment of the falsification end points heart failure, stroke, and pneumonia. A prespecified subgroup included patients treated from February 22, 2016, through December 31, 2017, corresponding to the market release of the most contemporary unibody aortic stent grafts (Endologix AFX2 AAA stent graft). Results:Of 87 163 patients who underwent aortic stent grafting at 2146 US hospitals, 11 903 (13.7%) received a unibody device. The average age of the total cohort was 77.0 +/- 6.7 years, 21.1% were female, 93.5% were White, 90.8% had hypertension, and 35.8% used tobacco. The primary end point occurred in 73.4% of unibody device-treated patients versus 65.0% of non-unibody device-treated patients (hazard ratio, 1.19 [95% CI, 1.15-1.22]; noninferior P value of 1.00; median follow-up, 3.4 years). Falsification end points were negligibly different between groups. In the subgroup treated with contemporary unibody aortic stent grafts, the cumulative incidence of the primary end point occurred in 37.5% of unibody device-treated patients and 32.7% of non-unibody device-treated patients (hazard ratio, 1.06 [95% CI, 0.98-1.14]). Conclusions:In the SAFE-AAA Study, unibody aortic stent grafts failed to meet noninferiority compared with non-unibody aortic stent grafts with respect to aortic reintervention, rupture, and mortality. These data support the urgency of instituting a prospective longitudinal surveillance program for monitoring safety events related to aortic stent grafts.

Background: Medicare Advantage plans now provide health insurance coverage to >24 million older adults in the United States, and enrollment is increasing among individuals with cardiovascular disease (CVD). Whether Medicare Advantage enrollment is associated with similar health care access, acute care utilization, and financial strain for adults with CVD compared with traditional Medicare is unknown. Methods: We performed a cross-sectional study of Medicare beneficiaries 65 years or older with CVD using the 2019 National Health Interview Survey. We fit multivariable logistic regression models to examine the association of Medicare program type (Medicare Advantage versus traditional Medicare) with measures of health care access, acute care utilization, and affordability. Results: The weighted population included 11 013 437 Medicare beneficiaries, of whom 3 922 104 (35.6%) were enrolled in Medicare Advantage, and 7 091 334 (64.4%) were enrolled in traditional Medicare. Medicare Advantage and traditional Medicare enrollees were similar with respect to age, sex, racial/ethnic distribution, and household income; however, Medicare Advantage beneficiaries were more likely to live in an urban setting (82.7% versus 76.0%; P =0.01) and to be college educated (24.2% versus 19.0%; P =0.01). Medicare Advantage beneficiaries were more likely to have a usual source of care (93.5% versus 88.9%; OR, 1.99 [95% CI, 1.33–2.98)]; however, there were no other differences in health care access or utilization. Medicare Advantage beneficiaries were more likely to have problems paying medical bills (16.5% versus 11.6%; OR, 1.68 [1.17–2.40]) and to worry about paying medical bills (40.1% versus 33.8%; OR, 1.37 [1.07–1.76]) compared with those enrolled in traditional Medicare. Conclusions: Adults with CVD in Medicare Advantage were more likely to experience financial strain related to their medical bills compared with those in traditional Medicare. As enrollment in Medicare Advantage grows, policy efforts should focus on ensuring care is affordable for patients with CVD.

Background: Although the effectiveness of buprenorphine-naloxone (BUP-NX) has been established, real-world evidence on the benefits of early treatment initiation is limited. Objective: To evaluate the association between early BUP-NX initiation and health-related outcomes among insured adults with opioid use disorder (OUD). Methods: We conducted a cross-sectional analysis using the Optum’s de-identified Clinformatics® Data Mart Database from 2010 to 2018. Patients who initiated BUP-NX within 30 days of OUD diagnosis were classified as early initiators. Patients who initiated BUP-NX later, but within the one-year follow-up, were defined as late initiators. Outcomes included opioid overdose, opioid overdose-related emergency department (ED) visits, and all-cause healthcare cost during the year after OUD diagnosis. We employed generalized linear models to compare outcomes between early and late initiators, adjusting for baseline covariates and accounting for missing information for covariates using multiple imputation. Results: A total of 8,388 patients with OUD were identified; mean age was 39.9 years; 36% were female; and 67.6% were early initiators. Early initiators had an estimated 42% lower rate of opioid overdose (adjusted rate ratio (aRR) = 0.58; 95% confidence interval (CI): 0.52, 0.64); 51% lower rate of opioid overdose-related ED visits (aRR = 0.49; 95% CI: 0.44, 0.55); and 31% lower total healthcare cost (adjusted cost ratio = 0.69; 95% CI: 0.66, 0.72), compared to late initiators. Conclusion: Compared to late BUP-NX initiation, early initiation was associated with a lower risk of opioid overdose and opioid overdose-related ED visits, and reduced total healthcare cost among insured adult patients with OUD.

This retrospective cohort study evaluated the comparative vaccine effectiveness (cVE) of licensed standard‐dose cell‐based versus egg‐based influenza vaccines in preventing influenza hospitalization among adults 18–64 years during the 2022–2023 season. The cohort included eligible Kaiser Permanente Southern California members who received ≥ 1 dose of influenza vaccine (n = 848,334). The adjusted cVE against influenza hospitalization was −10.1% (95% CI: −49.8%, 37.8%) in the 18‐ to 49‐year‐old cohort. In the 50‐ to 64‐year‐old cohort, the adjusted cVE was 14.9% (−33.8%, 52.1%). Cell‐based and egg‐based influenza vaccines conferred comparable protection against influenza hospitalization in adults 18–64 years of age in the 2022–2023 season.